JP2017144028A - Catheter assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To cause a hub to reliably and efficiently assemble and hold a seal member.SOLUTION: A catheter assembly 10 includes a catheter 12, and a catheter hub 14. A hollow part 22 of the catheter hub 14 includes a hemostatic valve 24, a porous seal member 48, and a support member 50. The support member 50 includes: a hub mounting part 56 to be mounted on an inner peripheral surface of the catheter hub 14 constituting the hollow part 22; a first portion 54 inserted into the hemostatic valve 24 to apply friction force to the hemostatic valve 24; and a second portion 58 inserted in the seal member 48 to apply friction force to the seal member 48.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a catheter assembly that enables infusion and blood collection to a patient, for example, by being inserted and placed in a blood vessel of the patient.

  When infused into a patient, a doctor or nurse or the like uses a catheter assembly to puncture the patient with the catheter and the inner needle, and pulls out only the inner needle after the puncture to hold the catheter and the catheter. Place the hub on the patient side. And an infusion line is constructed | assembled by connecting a catheter hub and an infusion tube.

  This type of catheter assembly is provided with a hemostasis valve (valve element) for preventing blood leakage and a cylindrical pusher (insertion), for example, as disclosed in Patent Document 1, in order to improve the connectivity of an infusion tube. Member) inside the catheter base (catheter hub). When the infusion tube is connected, the catheter hub penetrates the valve body by the insertion member being pushed in by the connector of the infusion tube. This allows infusion from the connector to the catheter.

Japanese Patent No. 4999615

  By the way, the catheter assembly disclosed in Patent Document 1 introduces air in the outer peripheral surface of the valve body in order to guide blood into the catheter hub, so that the air in the hollow portion on the tip side of the valve body is removed. Configured to pull out. However, if air bleeding grooves are provided on the outer peripheral surface of the valve body in this way, blood that has flowed into the hollow portion through the air bleeding grooves may leak in the proximal direction of the valve body.

  As a means for preventing blood leakage, it is conceivable to provide a sealing member that allows air to pass therethrough but does not allow blood to pass therethrough on the base end side of the valve body. However, this type of sealing member is configured to be small and flexible, so that the posture tends to collapse when inserted into the catheter hub and fixed (poor assemblability), and the manufacturing efficiency of the catheter hub is reduced. Cause.

  The present invention has been made in order to solve the above-described problems, and a catheter that can prevent blood leakage satisfactorily by assembling and holding a seal member to a hub reliably and efficiently with a simple configuration. An object is to provide an assembly.

  In order to achieve the above object, a catheter assembly according to the present invention includes a catheter, a hub having a hollow portion that holds the catheter on a distal end side and communicates with a lumen of the catheter, and the hollow portion. A porous body that is disposed in the hollow portion on the base end side with respect to the valve body, and that allows outflow of gas in the base end direction while blocking outflow of liquid in the base end direction And a support member formed separately from the seal member and disposed in the hollow portion, the support member being fitted to the valve body and holding the valve body. It has 1 holding | maintenance part and the 2nd holding | maintenance part which fits the said sealing member and hold | maintains the said sealing member, It is characterized by the above-mentioned.

  According to the above, the support member of the catheter assembly can hold the valve body and the seal member together and can be housed and fixed in the hub. That is, the catheter assembly can hold the valve body and the seal member securely and efficiently in the hub with a simple structure of the support member, and the productivity is improved. Further, the seal member fixed by the support member can block the blood flow in the hub and prevent the blood leakage well.

  In this case, the support member may include a hub attachment portion that is aligned with the first and second holding portions in the axial direction and is attached to the inner surface of the hub constituting the hollow portion.

  As described above, since the support member has the hub mounting portion, the catheter assembly can firmly fix the support member in the hub, and can favorably suppress the displacement of the valve body and the seal member. .

  In addition to the above configuration, it is preferable that the first holding portion protrudes from the hub attachment portion in the distal direction, and the second holding portion protrudes from the hub attachment portion in the proximal direction.

  As described above, the support member has the first holding portion protruding in the distal direction and the second holding portion protrudes in the proximal direction, so that the valve body and the seal member can be easily removed from the distal end and the proximal end of the support member, respectively. Can be inserted and fitted. Therefore, the work efficiency at the time of assembly can be further improved.

  Further, the hub attachment portion may be provided with one or more communication portions that communicate the space on the distal end side with respect to the hub attachment portion and the space on the proximal end side with respect to the hub attachment portion.

  As described above, the catheter assembly includes one or more communication portions in the hub attachment portion, whereby the gas on the distal end side than the hub attachment portion can smoothly flow to the proximal end side from the hub attachment portion. Therefore, gas flows out favorably in the proximal direction through the seal member.

  Furthermore, it is preferable that the outer peripheral surface of the hub attachment portion is provided with a notch portion that circulates in the circumferential direction and communicates the space on the tip end side with respect to the hub attachment portion and the communication portion.

  As described above, the catheter assembly includes the notch portion that circulates in the circumferential direction on the outer peripheral surface of the hub attachment portion, so that the gas that has flowed to the hub attachment portion through the outside of the valve body is temporarily provided in the circumferential direction of the hub. It can be made to flow. Therefore, even if the circumferential position where the gas flows out is different from the position where the communication portion is formed, the gas can be reliably guided to the communication portion.

  Here, the support member may include a valve body displacement restricting unit that restricts a displacement of the valve body in an axial direction with respect to the first holding portion.

  As described above, since the support member has the valve body displacement regulating means, the valve body and the support member can be more firmly fixed, and the displacement of the valve body can be more reliably suppressed.

  In addition, the support member may include a seal member deviation regulating unit that regulates an axial positional deviation of the seal member with respect to the second holding portion.

  As described above, since the support member has the seal member deviation regulating means, the seal member and the support member can be more firmly fixed, and the positional deviation of the seal member can be more reliably suppressed.

  And it is preferable that the said 2nd holding | maintenance part is formed thinner than the said 1st holding | maintenance part.

  Thus, since the second holding portion is formed thinner than the first holding portion, it is possible to employ a relatively thick seal member in the radial direction, and the function of the seal member can be sufficiently exhibited. it can.

  Furthermore, it is preferable that the axial length of the second holding portion is longer than the axial length of the seal member.

  Thus, since the axial length of the second holding portion is longer than the axial length of the seal member, the second holding portion can apply a frictional force evenly along the axial direction of the seal member. In addition, it is possible to suppress breakage of the seal member, deterioration in function, and the like.

  Still further, the seal member may be a sintered body.

  If the seal member, which is a sintered body, is small and has a special shape, it takes time and effort to manufacture, but this catheter assembly is configured to fix the seal member with a support member. Can be made into a simple shape such as a ring shape and its volume can be reduced. Thereby, it becomes possible to make a sealing member easily, the manufacturing efficiency of the whole catheter assembly can be improved, and the manufacturing cost can be reduced.

  According to the present invention, with a simple configuration, the catheter assembly can reliably and efficiently assemble and hold the seal member on the hub, thereby preventing blood leakage well.

It is a perspective view showing the whole catheter assembly composition concerning one embodiment of the present invention. FIG. 2 is an exploded perspective view of the catheter assembly of FIG. 1. 3A is a side cross-sectional view showing the internal structure of the catheter hub of FIG. 1, and FIG. 3B is an enlarged side cross-sectional view showing an axial intermediate portion of the catheter hub of FIG. 3A. FIG. 4A is an enlarged perspective view showing the support member, and FIG. 4B is a side sectional view showing the relationship between the hemostasis valve, the support member, and the seal member. 5A is a sectional view taken along line VA-VA in FIG. 3A, FIG. 5B is a sectional view taken along line VB-VB in FIG. 3A, and FIG. 5C is a sectional view taken along line VC-VC in FIG. 6A is a first side sectional view showing the operation of the catheter assembly of FIG. 3A, and FIG. 6B is a second side sectional view showing the operation of the catheter assembly following FIG. 6A. FIG. 6B is a third side cross-sectional view illustrating the operation of the catheter assembly of FIG. 6B. FIG. 8A is a partial side sectional view of a catheter assembly according to a first modification, FIG. 8B is a partial side sectional view of a catheter assembly according to a second modification, and FIG. 8C is a third modification. FIG. 8D is a partial side cross-sectional view of a catheter assembly according to a fourth modification. 9A is a partial side sectional view of a catheter assembly according to a fifth modification, FIG. 9B is a partial side sectional view of a catheter assembly according to a sixth modification, and FIG. 9C is a seventh modification. FIG. 9D is a partial side cross-sectional view of a catheter assembly according to an eighth modification.

  Hereinafter, preferred embodiments of the catheter assembly according to the present invention will be described in detail with reference to the accompanying drawings.

  As shown in FIG. 1, the catheter assembly 10 according to the present embodiment includes a catheter 12 (outer needle), a catheter hub 14 that connects and holds the proximal end of the catheter 12, and an inner needle that penetrates the catheter 12. 16 and an inner needle hub 18 that holds the proximal end of the inner needle 16.

  A user such as a doctor or nurse grasps the inner needle hub 18 of the catheter assembly 10 when constructing the infusion line, and punctures the blood vessel of the patient. The distal end portion of the catheter assembly 10 has the catheter 12 and the inner needle 16 overlapped at the time of puncturing (hereinafter also referred to as a puncturable state), and is inserted integrally into the blood vessel of the patient. In the puncture enabled state, the proximal end side of the catheter hub 14 and the distal end side of the inner needle hub 18 are connected, and the inner needle hub 18 supports the catheter hub 14.

  After puncturing the patient, the user pulls out (retracts) the inner needle hub 18 in the proximal direction relative to the catheter hub 14, thereby detaching the inner needle hub 18 from the catheter hub 14. With this retraction, the inner needle 16 held by the inner needle hub 18 is also retracted integrally and pulled out from the catheter 12 and the catheter hub 14. As a result, the inner needle 16 is removed from the blood vessel of the patient, and on the patient side, the distal end side of the catheter 12 is in the blood vessel, and the proximal end side of the catheter 12 and the catheter hub 14 are exposed on the skin. Thereafter, an infusion solution (medical solution) is administered from the infusion tube to the patient by connecting the connector 20 (see FIG. 7) of the infusion tube to the proximal end side of the catheter hub 14 in the indwelling state. Hereinafter, the configuration of the catheter assembly 10 will be specifically described.

  The catheter 12 is configured as a tubular member that is flexible and can be continuously inserted into a blood vessel of a patient. A lumen 12 a is formed in the catheter 12 so as to extend in the axial direction and allow the inner needle 16 to be inserted therethrough. The proximal end portion of the catheter 12 is inserted and fixed in the catheter hub 14.

  The constituent material of the catheter 12 is not particularly limited, but a resin material, particularly a soft resin material, is suitable. For example, polytetrafluoroetherene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE). ), Fluorinated resins such as belfluoroalkoxy fluororesin (PFA), olefinic resins such as polyethylene and polypropylene, or mixtures thereof, polyurethane, polyester, polyamide, polyether nylon resin, the olefinic resin and ethylene-vinyl acetate Examples thereof include a mixture with a polymer.

  Moreover, the catheter 12 is good to have transparency so that all or part of the inside can be visually recognized. Thereby, it is possible to visually confirm the flashback in which blood flows into the catheter hub 14 through the lumen 12a of the catheter 12 with the catheter 12 inserted into the blood vessel.

  The catheter hub 14 that holds the catheter 12 is interposed between the catheter 12 and the infusion tube and has a function of connecting (communicating) both members easily and reliably. The catheter hub 14 is formed in a cylindrical shape that tapers in the distal direction, and is stuck on the patient's skin with a tape or the like and placed. An operation protrusion 14a for pushing the catheter 12 into the blood vessel at the time of puncture is formed on the upper portion of the catheter hub 14 so as to protrude.

  The catheter hub 14 is preferably made of a material harder than the catheter 12. Although the constituent material of the catheter hub 14 is not particularly limited, for example, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer can be suitably used.

  Inside the catheter hub 14, there is provided a hollow portion 22 that is formed so as to penetrate in the axial direction and communicate with the proximal end opening 22 a of the catheter hub 14 so that an infusion solution can flow therethrough. Moreover, as shown in FIG. 2, the hemostatic valve 24 (valve body), the interruption | blocking mechanism part 26, and the plug 30 (insertion member) are accommodated in the hollow part 22. As shown in FIG. Each of these members will be described in detail later.

  On the other hand, the inner needle 16 of the catheter assembly 10 is configured as a tubular member having rigidity capable of puncturing the patient's skin. Examples of the constituent material of the inner needle 16 include metal materials such as stainless steel, aluminum, aluminum alloy, titanium, and titanium alloy. The inner needle 16 is formed sufficiently longer than the catheter 12, and a sharp needle tip 16 a protrudes from the distal end opening of the catheter 12 in a puncturable state. Further, the inner needle 16 extends linearly through the lumen 12 a of the catheter 12 and the hollow portion 22 of the catheter hub 14, and its proximal end is fixedly held by an inner needle holding member (not shown) in the inner needle hub 18. Has been.

  Returning to FIG. 1, the inner needle hub 18 that holds the inner needle 16 is formed in a long casing that can be gripped by the user and stably operate the double tube body of the catheter 12 and the inner needle 16. Yes. A housing mechanism (not shown) that houses the inner needle 16 when the inner needle hub 18 is detached from the catheter hub 14 may be provided inside the inner needle hub 18.

  Next, the internal structure of the catheter hub 14 will be specifically described with reference to FIGS. The hollow portion 22 of the catheter hub 14 has a holding space 32, a guide space 34, a mechanism arrangement space 36, and a connection space 38 in this order from the distal end side to the proximal end side. Adjacent spaces communicate with each other.

  The holding space 32 is a space for holding the proximal end portion of the catheter 12 on the distal end side of the catheter hub 14. The catheter 12 is inserted into a holding space 32 and a caulking pin (not shown) is caulked by being inserted into the holding space 32 so that the inner peripheral surface of the catheter hub 14 constituting the holding space 32 and the caulking pin are connected. It is firmly fixed between. The means for fixing the catheter 12 and the catheter hub 14 is not particularly limited. For example, an appropriate joining method such as fusion (thermal fusion, high-frequency fusion, etc.), adhesive bonding, or other caulking. Can be taken.

  The guide space 34 is a space portion that guides the infusion agent flowing out from the connector 20 to the lumen 12 a of the catheter 12. Therefore, the inner peripheral surface of the catheter hub 14 constituting the guide space 34 is formed in a funnel shape in which the distal end side gradually becomes smaller in diameter toward the holding space 32, while the intermediate side and the proximal end side have the same diameter. A predetermined volume is ensured.

  The mechanism arrangement space 36 is a space where the hemostasis valve 24 and the blocking mechanism 26 are arranged, and is formed with a slightly larger diameter than the guide space 34, thereby forming a step 35 with respect to the guide space 34. Further, on the inner peripheral surface of the catheter hub 14 constituting the mechanism arrangement space 36, in a sectional view (see FIG. 5A), a support surface 40 for supporting the hemostasis valve 24 and the support surface 40 are cut shallowly radially outward. A plurality (eight in FIG. 5A) of concave grooves 42 are provided. The plurality of concave grooves 42 are formed at equal intervals along the circumferential direction of the inner peripheral surface, and extend in a length corresponding to the hemostatic valve 24 along the axial direction of the hollow portion 22. The tip of the groove 42 communicates with the guide space 34 through the step 35.

  As shown in FIGS. 3A and 3B, the hemostasis valve 24 is a cylindrical elastic member having a cylindrical side wall 24a and a bottom wall 24b that closes the distal end side of the side wall 24a. In the center of the bottom wall 24b of the hemostasis valve 24, a slit 24c through which the inner needle 16 and the plug 30 can pass is formed.

  The hemostasis valve 24 is arranged so as to divide the hollow portion 22 of the catheter hub 14 into a distal end side hollow portion 44 and a proximal end side hollow portion 46, and the blood flowing into the distal end side hollow portion 44 is blocked by the bottom wall 24b. . The side wall 24 a of the hemostasis valve 24 is supported by the support surface 40 in the arrangement state of the mechanism arrangement space 36. In this state, the air existing in the distal end side hollow portion 44 can be moved in the proximal direction through the concave groove 42 by the concave groove 42 extending to the side of the side wall 24a.

  Examples of the elastic material constituting the hemostasis valve 24 include various rubber materials such as natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluorine rubber, and silicone rubber ( In particular, those obtained by vulcanization), various thermoplastic elastomers such as urethane, polyester, polyamide, olefin, and styrene, and mixtures thereof.

  The blocking mechanism portion 26 inserted and arranged on the proximal end side of the hemostasis valve 24 fixes the hemostasis valve 24 and allows air flowing in the concave groove 42 to flow to the proximal end side hollow portion 46, while the proximal end It has a function of blocking the blood flow to the side hollow portion 46. Specifically, the blocking mechanism portion 26 includes a seal member 48 and a support member 50.

  The sealing member 48 of the blocking mechanism portion 26 is a structure that is porous so as to allow gas to pass while not allowing liquid to pass therethrough, and has a relatively large through-hole 48a inside thereof. Have The seal member 48 is formed in an annular shape in which a distal end surface and a proximal end surface orthogonal to the axial direction are parallel, and an inner peripheral surface and an outer peripheral surface are parallel to the axial direction. The outer diameter of the seal member 48 is formed to be equal to or slightly larger than the diameter of the mechanism arrangement space 36. Thereby, the seal member 48 is in close contact with the inner peripheral surface constituting the mechanism arrangement space 36 in the assembled state to the catheter hub 14. Further, the seal member 48 is formed thicker than the side wall 24 a of the hemostasis valve 24.

  The material which comprises the sealing member 48 is not specifically limited, For example, what formed the sintered compact by heating the powder of resin materials, such as polyethylene and a polypropylene, can be used suitably. Moreover, the sealing member 48 can be easily formed by punching from a base material configured as a sintered body by adopting the shape described above.

  The support member 50 of the blocking mechanism portion 26 is disposed between the hemostatic valve 24 and the seal member 48 and has a function of fixing and supporting these members. As shown in FIG. 4A, the support member 50 has a substantially cylindrical shape as a whole, and a hole portion 52 is provided inside the support member 50 along the axial direction. The inner peripheral surface which comprises the hole part 52 is formed in parallel along the axial direction. The support member 50 includes, in order from the distal end side, a first holding portion 54 (hereinafter abbreviated as a first portion 54), a hub mounting portion 56, and a second holding portion 58 (hereinafter abbreviated as a second portion 58). Is provided.

The first portion 54 is a portion that protrudes from the hub attachment portion 56 by a predetermined length in the distal direction. As shown in FIG. 4B, the outer diameter φ ₁ is the same as the inner diameter φ _B of the side wall 24a of the hemostasis valve 24. Or it is set to a slightly larger diameter. The axial length of the first portion 54 is shorter than the axial length of the side wall 24 a and is in close contact with the proximal end side of the side wall 24 a of the hemostasis valve 24. As a result, the hemostasis valve 24 has a wider space near the bottom wall 24b, and the head 60 of the plug 30 described later is disposed in a free state. The first portion 54 is inserted and fitted into the hemostasis valve 24 in an assembled state with the catheter hub 14, and applies a frictional force to the side wall 24a by expanding the side wall 24a radially outward. Further, the first portion 54 firmly fixes the hemostasis valve 24 to the catheter hub 14 by sandwiching the hemostasis valve 24 with the support surface 40 of the catheter hub 14.

  The hub attachment portion 56 is a bowl-shaped portion that protrudes radially outward from the first portion 54 and the second portion 58 and circulates in the circumferential direction. The hub attachment portion 56 is set so that its outer diameter is equal to or larger than the diameter of the mechanism arrangement space 36, and is in close contact with the inner peripheral surface of the catheter hub 14 in the assembled state with the catheter hub 14. The axial length of the hub mounting portion 56 is not particularly limited, but may be set shorter than the axial lengths of the first portion 54 and the second portion 58.

  As shown in FIGS. 4A and 5B, a plurality (eight in FIG. 5B) of groove portions 56 a (circulation portions 57) are provided on the outer peripheral surface of the hub attachment portion 56. The plurality of groove portions 56 a extend in a straight line parallel to the axial direction of the support member 50, and are arranged at equal intervals along the circumferential direction of the hub attachment portion 56. The groove part 56a is shallowly formed radially inward from the outer peripheral surface of the hub attachment part 56 (for example, 1/5 or less of the wall thickness of the hub attachment part 56), and mainly allows gas to flow.

  Further, an annular notch 56b is provided along the circumferential direction at the tip of the outer peripheral surface of the hub mounting portion 56. The cutout portion 56b is formed by obliquely cutting off the front end side corner portion of the outer peripheral surface, and is continuous with the front end side of each groove portion 56a. That is, each groove part 56a is mutually connected via the notch part 56b.

On the other hand, the second portion 58 is a portion protruding from the hub mounting portion 56 by a predetermined length in the proximal direction, and its outer diameter φ ₂ is set to be slightly larger than the inner diameter φ _S of the seal member 48. . The second portion 58 is inserted and fitted into the through hole 48a of the seal member 48 in the assembled state with the catheter hub 14, and pushes the seal member 48 radially outward so that the seal member 48 is expanded. Apply frictional force. The second portion 58 firmly fixes the seal member 48 to the catheter hub 14 by sandwiching the seal member 48 with the inner surface of the catheter hub 14 constituting the mechanism arrangement space 36. The axial length of the second portion 58 is preferably set to be equal to or longer than the axial length of the seal member 48. As a result, the second portion 58 is in close contact with the seal member 48 with an equal force.

  Returning to FIG. 3A, the connection space 38 of the catheter hub 14 extends from the mechanism arrangement space 36 to the proximal end opening 22 a of the catheter hub 14. The connection space 38 is set to a diameter that allows the connector 20 of the infusion tube to be inserted and fitted. Note that the inner peripheral surface of the catheter hub 14 constituting the connection space 38 is preferably formed in a tapered shape with a gradually decreasing diameter in the distal direction in order to improve the connectivity with the connector 20.

  The plug 30 is formed in a cylindrical shape that is elongated in the axial direction, and is disposed in the hollow portion 22 so as to be freely displaceable. The plug 30 passes through the slit 24 c of the hemostasis valve 24 and is displaced in the distal direction as the connector 20 is inserted, so that the infusion agent supplied from the connector 20 can be introduced into the distal end side hollow portion 44. Specifically, the plug 30 has a head portion 60, a body portion 62, and a flange portion 64 from the distal end toward the proximal end side, and a flow passage 66 through which an infusion solution can flow is formed in each part. Has been.

  The head portion 60 includes a claw portion 60 a that constitutes the distal end portion of the plug 30 and protrudes radially outward with respect to the body portion 62 and circulates in an annular shape. The head 60 is disposed in the hemostasis valve 24 between the bottom wall 24b and the support member 50 (first portion 54) with the connector 20 not inserted. The plug 30 can be prevented from coming out in the proximal direction because the claw portion 60a can be hooked on the first portion 54. The head 60 is easily disposed in the distal end side hollow portion 44 by being pushed out toward the distal end when the connector 20 is inserted.

  The body portion 62 is formed in a cylindrical shape extending a predetermined length from the head portion 60 toward the proximal direction, and the flange portion 64 is disposed on the proximal end side of the connection space 38 in a state where the connector 20 is not inserted. Yes. The flange portion 64 is formed in a substantially disc shape that protrudes largely radially outward from the base end of the body portion 62, and the base end portion on the peripheral side slightly protrudes in the base end direction.

  Next, the manufacturing procedure of the catheter assembly 10 will be described. In manufacturing the catheter assembly 10, first, the catheter hub 14 and the catheter 12 are fixed by caulking pins. Next, the internal structure (the hemostasis valve 24 and the blocking mechanism portion 26) formed in a separate forming process is inserted into the hollow portion 22 of the catheter hub 14. Here, the sealing member of the shut-off mechanism is a small sintered body, and if a complicated shape such as a cylindrical outer diameter changes is adopted, it is necessary to perform molding individually during the molding process. It takes time and money.

  In contrast, the catheter assembly 10 according to the present embodiment can be supported by the support member 50 by forming the seal member 48 into a simple ring shape. For this reason, the sealing member 48 can be easily made by forming a sintered body (base material) into a plate shape and then punching it into a ring shape with a die cutting machine at the time of the forming step. As a result, the manufacturing efficiency of the entire catheter assembly 10 can be improved and the manufacturing cost can be reduced. Further, since the amount of each sealing member 48 itself is small, a low-cost catheter assembly 10 can be produced.

  When the internal structure is accommodated in the catheter hub 14, the hemostasis valve 24 is attached to the first portion 54 of the support member 50, and the seal member 48 is attached to the second portion 58 of the support member 50. 22 is inserted. Thus, the hemostasis valve 24, the support member 50, and the seal member 48 in the hollow portion 22 are inserted into the mechanism arrangement space 36 while maintaining the postures of the hemostasis valve 24, the support member 50, and the seal member 48 without being tilted. 50 can be fitted.

  Here, in assembling the catheter assembly 10, a configuration in which the hemostasis valve 24 or the seal member 48 is fixedly held by fusing the hemostasis valve 24 or the seal member 48 to the support member 50 is also conceivable. However, the implementation of such fusion requires a separate manufacturing process, which greatly reduces work efficiency and increases manufacturing cost. The catheter assembly 10 according to this embodiment is configured such that the first portion 54 of the support member 50 fits and holds the hemostasis valve 24 and the second portion 58 fits and holds the seal member 48. The wearing process can be eliminated. As a result, the work efficiency can be improved and the manufacturing cost can be reduced.

  When the support member 50 is fitted to the catheter hub 14, the first portion 54 sandwiches the side wall 24 a of the hemostasis valve 24 between the first portion 54 and the inner peripheral surface of the catheter hub 14. As a result, the hemostasis valve 24 is applied with a strong frictional force from the catheter hub 14 and the support member 50 to prevent displacement. Similarly, the second portion 58 sandwiches the seal member 48 between the inner peripheral surface of the catheter hub 14. As a result, the seal member 48 is applied with a strong frictional force from the catheter hub 14 and the support member 50, thereby preventing displacement.

  Thereafter, the plug 30 is inserted into the hollow portion 22, and the head 60 of the plug 30 is inserted from the bottom wall 24 b of the hemostasis valve 24 to the proximal end side and from the support member 50 to the distal end side. Then, the inner needle 16 is inserted into the catheter 12 and the catheter hub 14. At the time of this insertion, the proximal end of the inner needle 16 may be inserted from the distal end opening of the catheter 12. As a result, the needle 16a of the inner needle 16 is prevented from piercing the hemostasis valve 24, the blocking mechanism portion 26, the plug 30, and the like, and smoothly penetrates the hollow portion 22. Finally, the assembled catheter hub 14 is held by the inner needle hub 18, and the proximal end portion of the inner needle 16 is fixed to the inner needle hub 18, so that the punctureable state as shown in FIGS. 1 and 3A is achieved. A catheter assembly 10 is formed.

  The catheter assembly 10 according to the present embodiment is basically configured as described above, and the effects thereof will be described below.

  When infusing a patient, a user (such as a doctor or nurse) operates the inner needle hub 18 of the catheter assembly 10 to puncture the catheter 12 and the inner needle 16 into the blood vessel of the patient. As a result, the blood of the patient flows inside the inner needle 16. Then, while maintaining the puncture state of the catheter 12, the inner needle 16 and the inner needle hub 18 are retracted in the proximal direction from the catheter 12 and the catheter hub 14, as shown in FIG. 6A. As a result, the patient's blood flows through the lumen 12 a of the catheter 12 and flows into the hollow portion 22 of the catheter hub 14.

  At this time, the air present in the hollow portion 22 (the distal end side hollow portion 44) is pushed out in the proximal direction by the inflow pressure of blood. The air flows into the plurality of concave grooves 42 provided on the inner peripheral surface of the catheter hub 14 and flows in the concave direction toward the proximal end. Then, when the air reaches the support member 50 from the concave groove 42, the air wraps around in the circumferential direction of the support member 50 (inner peripheral surface of the catheter hub 14) through the notch 56b. Further, air flows into the plurality of grooves 56 a from the notches 56 b, flows in the grooves 56 a in the proximal direction, and reaches the seal member 48.

  Since the seal member 48 is configured to allow air (gas) to pass therethrough, the air can be directly passed in the proximal direction. As a result, the air flows out from the proximal end hollow portion 46 of the catheter hub 14 through the proximal end opening 22 a to the outside, and blood gradually flows into the distal end side hollow portion 44.

  As shown in FIG. 6B, when the inner needle 16 is removed from the hemostasis valve 24, the blood fills the distal end side hollow portion 44, and a part of the blood flows into the concave grooves 42 of the catheter hub 14 in the proximal direction. Head. Here, since the groove part 56a of the support member 50 is formed smaller than the concave groove 42, blood can be prevented from flowing into the groove part 56a. Therefore, the catheter assembly 10 can prevent blood from flowing out into the proximal end side hollow portion 46.

  After detaching the inner needle 16 and the inner needle hub 18 from the catheter 12 and the catheter hub 14, the user inserts the infusion tube connector 20 from the proximal opening 22a of the catheter hub 14, as shown in FIG. The distal end portion of the connector 20 comes into contact with the proximal end of the plug 30 as it is inserted and pushes the plug 30 in the distal end direction so that the plug 30 passes through the slit 24c of the hemostasis valve 24 and enters the guide space 34 into the head 60. Place. As a result, the catheter assembly 10 communicates with the lumen 12a of the catheter 12, the distal end side hollow portion 44 of the catheter hub 14, the flow passage 66 of the plug 30, and the supply path of the connector 20, so that an infusion solution is introduced into the blood vessel of the patient. Can be fed satisfactorily.

  Here, blood may flow into the proximal direction by entering the groove 56a due to an increase in pressure accompanying the entry of the plug 30, or a capillary phenomenon. However, the blood is further blocked from flowing in the proximal direction by the seal member 48 disposed on the proximal end side of the hub attachment portion 56. That is, the catheter assembly 10 more reliably prevents blood leakage by the presence of the sealing member 48 on the proximal side that does not allow liquid to pass even if blood flows through the groove portion 56a of the support member 50. Can do.

  As described above, the catheter assembly 10 according to the present embodiment can accommodate and fix the hemostasis valve 24 and the seal member 48 together in the catheter hub 14 by the support member 50. That is, the catheter assembly 10 can reliably and efficiently assemble and hold the hemostasis valve 24 and the seal member 48 in the catheter hub 14 with a simple configuration of the support member 50, and the productivity thereof is improved. Further, the seal member 48 fixed by the support member 50 can block the blood flow in the catheter hub 14 and prevent the blood leakage well.

  In this case, the support member 50 is configured in the order of the first portion 54, the hub attachment portion 56, and the second portion 58, thereby giving sufficient frictional force from the first portion 54 to the hemostasis valve 24, A sufficient frictional force can be applied from 58 to the seal member 48. Further, the catheter assembly 10 includes a plurality of groove portions 56 a in the hub attachment portion 56, so that the air flowing from the concave groove 42 of the catheter hub 14 can flow more smoothly to the proximal end side than the hub attachment portion 56. Can do. Therefore, the air flows out well in the proximal direction through the seal member 48.

  Further, the catheter assembly 10 includes notches 56b that circulate in the circumferential direction on the outer peripheral surface of the hub attachment portion 56, so that the air that has flowed through the plurality of concave grooves 42 is temporarily provided in the circumferential direction of the catheter hub 14. It can be made to flow. Therefore, even if the catheter assembly 10 is assembled with the formation positions of the plurality of concave grooves 42 and the formation positions of the plurality of groove portions 56a different from each other, the catheter assembly 10 can reliably guide air to the groove portions 56a. In other words, the support member 50 can be easily assembled without positioning the circumferential position of the support member 50 with respect to the catheter hub 14.

  Furthermore, since the second portion 58 is formed thinner than the first portion 54, the catheter assembly 10 can employ a relatively thick seal member 48 in the radial direction. Can be fully exhibited. Furthermore, since the axial length of the second portion 58 is longer than the axial length of the seal member 48, the second portion 58 can apply a frictional force evenly along the axial direction of the seal member 48. It is possible to suppress breakage of the seal member 48 and functional deterioration.

  The catheter assembly 10 is not limited to the above configuration, and various modifications can be made. For example, the support member 50 may be accommodated in the catheter hub 14 while holding the hemostasis valve 24 and the seal member 48, and may not include the hub attachment portion 56. Even in this case, the support member 50 presses the hemostasis valve 24 and the seal member 48 against the inner peripheral surface of the catheter hub 14, so that the hemostasis valve 24 and the seal member 48 can be fixed to prevent displacement.

  Further, the catheter assembly 10 may be provided with a spring (not shown) so as to be sandwiched between the proximal end surface of the seal member 48 and the flange portion 64 of the plug 30. For example, the spring is formed in a coil shape slightly smaller than the inner diameter of the connection space 38, and has a predetermined length in the axial direction (a dimension shorter than the body portion 62 of the plug 30). When the connector 20 is inserted into the connection space 38 and the plug 30 is pushed in the distal direction, the spring contracts in the axial direction and biases the plug 30 in the proximal direction. Therefore, when the connector 20 is detached from the connection space 38, the spring is elastically restored and pushes the plug 30 back in the proximal direction according to the entire length. As a result, when the connector 20 is pulled out at the end of the infusion or at the time of switching the infusion, the spring is restored and the plug 30 is automatically pushed back in the proximal direction, and the plug 30 is retracted from the hemostasis valve 24 and the slit 24c is opened. Block and prevent blood leakage. At this time, the head portion 60 of the plug 30 is hooked on the support member 50, so that the drop off from the catheter hub 14 is prevented.

  Hereinafter, several modifications of the present invention will be described with reference to FIGS. 8A to 9D. In addition, in the following description, about the structure which has the same structure as the catheter assembly 10 which concerns on this embodiment, or the same function, the same code | symbol is attached | subjected and the detailed description is abbreviate | omitted.

  A catheter assembly 10A (supporting member 50A) according to the first modification shown in FIG. 8A is different from the catheter assembly 10 in that it includes a base end side positional deviation regulating means 70 that regulates the positional deviation of the seal member 48. Specifically, the proximal side position deviation restricting means 70 is constituted by a return portion 71 provided in the second portion 58. The return portion 71 protrudes radially outward from the outer peripheral surface of the proximal end of the second portion 58 and sandwiches the seal member 48 between the hub attachment portion 56 and the return portion 71. As a result, the positional displacement of the seal member 48 beyond the return portion 71 toward the proximal end is well regulated.

  The catheter assembly 10B (supporting member 50B) according to the second modification shown in FIG. 8B is configured such that the proximal-end-side positional displacement restricting means 70 is configured by one or more protrusions 72. And different. The protruding portion 72 protrudes radially outward from the outer peripheral surface of the second portion 58. As a result, the protrusion 72 can apply a strong frictional force to the seal member 48 to reliably hold the seal member 48 and prevent displacement. The shape of the protrusion 72 is not particularly limited, and may be formed in an annular shape along the outer peripheral surface of the second portion 58, or may be formed in a spot shape, an arc shape, a spiral shape, or the like. Further, the inner peripheral surface of the seal member 48 may be configured to be linear in the axial direction and elastically deformed by the protrusion 72, and may have a groove that matches the protruding shape of the protrusion 72.

  The catheter assembly 10C (supporting member 50C) according to the third modification shown in FIG. 8C has the catheter assembly 10, 10A in that the proximal side position deviation restricting means 70 is constituted by one or more return needles 73. 10B. The return needle 73 protrudes from the proximal end surface of the hub attachment portion 56 in the proximal direction, has a return 73a at the proximal end portion, and can pierce the seal member 48 in the axial direction. When the return needle 73 is inserted, the seal member 48 is prevented from being removed from the return needle 73, and the positional deviation is restricted.

  In short, the installation location and shape of the base end side positional displacement restricting means 70 are not particularly limited. Further, for example, the proximal-side position deviation restricting means 70 can be configured by appropriately combining the above-described return portion 71, protrusion 72, return needle 73, and the like.

  The catheter assembly 10D (supporting member 50D) according to the fourth modification shown in FIG. 8D has a catheter assembly 10, 10A to 10C in that it has distal-end-side displacement regulating means 80 that regulates the displacement of the hemostatic valve 24. And different. The distal-end-side positional displacement restricting means 80 is configured, for example, by providing a return portion 81 on the distal-end outer peripheral surface of the first portion 54, similarly to the proximal-end-side positional displacement restricting means 70 according to the first modification. Thereby, the position shift of the hemostatic valve 24 in the hollow part 22 can be regulated favorably. Needless to say, the distal-end-side positional displacement restricting means 80 can be composed of one or more protrusions and a return needle, as in the second or third modification. Further, the support member 50 can be provided with both the base end side positional deviation regulating means 70 and the distal end side positional deviation regulating means 80.

  The catheter assembly 10E (supporting member 50E) according to the fifth modification shown in FIG. 9A has an air vent hole 90 that communicates the hub mounting portion 56 in the axial direction and the radial direction instead of the groove portion 56a. Different from the assemblies 10, 10A to 10D. The air vent hole 90 communicates with a notch portion 56 b provided in the hub attachment portion 56 and allows air flowing from the concave groove 42 to pass therethrough. In short, the flow part 57 that causes the gas of the support member 50 to flow in the proximal direction is not particularly limited, and various configurations can be adopted.

  In the catheter assembly 10F according to the sixth modification shown in FIG. 9B, the support member 50F does not have the groove portion 56a, and the concave groove 42 of the catheter hub 14 extends beyond the hub attachment portion 56 in the proximal direction. It has become the composition. In this case, the outer peripheral surface of the hub mounting portion 56 is contacted and supported by the support surface 40. The blood flowing in the concave groove 42 is blocked from leaking in the proximal direction by the seal member 48. As described above, the catheter assembly 10 </ b> F can block the passage of the liquid while allowing the gas to pass through the seal member 48 even if the support member 50 does not include the flow portion 57.

  The catheter assembly 10G (supporting member 50G) according to the seventh modification shown in FIG. 9C includes the catheter assemblies 10, 10A to 10F in that the catheter assembly 10G (support member 50G) has a protrusion 92 that protrudes toward the axial center of the hole 52. Different. For example, the protrusion 92 protrudes to a position close to the outer peripheral surface of the plug 30 at the tip of the support member 50, and more reliably restricts the plug 60 from coming off the head 60, and the plug 30 has an axial posture. Can be stabilized.

  The catheter assembly 10H (supporting member 50H) according to the eighth modification shown in FIG. 9D is configured in the order of a first part 54, a second part 58, and a hub attachment part 56 from the distal end toward the proximal end. Thus, it is different from the catheter assemblies 10, 10A to 10G. That is, the support member 50 can firmly fix each component by integrally pressing the hemostasis valve 24 and the seal member 48 closer to the front end side than the hub attachment portion 56. The blocking mechanism 26 allows the air flowing from the concave groove 42 of the catheter hub 14 to pass through the seal member 48 and the air vent hole 90, while blocking the blood flowing from the concave groove 42 by the sealing member 48. can do.

  The present invention is not limited to the above-described embodiment, and it goes without saying that various modifications can be made without departing from the gist of the present invention.

DESCRIPTION OF SYMBOLS 10, 10A-10H ... Catheter assembly 12 ... Catheter 14 ... Catheter hub 22 ... Hollow part 24 ... Hemostasis valve 24a ... Side wall 24b ... Bottom wall 30 ... Plug 36 ... Mechanism arrangement space 40 ... Support surface 42 ... Groove 44 ... Tip Side hollow part 46 ... Base end side hollow part 48 ... Seal members 50, 50A to 50H ... Support member 54 ... First part 56 ... Hub mounting part 56a ... Groove part 56b ... Notch part 57 ... Distribution part 58 ... Second part 70 ... Base-end-side positional deviation regulating means 80 ... Tip-side positional deviation regulating means

Claims (10)

A catheter;
A hub that holds the catheter on the distal end side and has a hollow portion that communicates with the lumen of the catheter;
A valve body provided in the hollow portion;
A porous sealing member that is disposed in the hollow portion on the proximal end side relative to the valve body, and that allows outflow of gas in the proximal direction, while blocking outflow of liquid in the proximal direction;
A support member formed separately from the seal member and disposed in the hollow portion,
The support member is
A first holding portion that fits the valve body and holds the valve body;
A catheter assembly, comprising: a second holding portion that is fitted to the seal member and holds the seal member. The catheter assembly of claim 1.
The catheter assembly, wherein the support member has a hub attachment portion that is aligned with the first and second holding portions in the axial direction and is attached to an inner surface of the hub constituting the hollow portion. The catheter assembly of claim 2,
The first holding part protrudes in the distal direction from the hub attachment part, and the second holding part protrudes in the proximal direction from the hub attachment part. The catheter assembly according to claim 2 or 3,
The hub attachment portion is provided with one or more communication portions that communicate the space on the distal end side with respect to the hub attachment portion and the space on the proximal end side with respect to the hub attachment portion. Solid. The catheter assembly according to claim 4.
On the outer peripheral surface of the hub attachment portion, a catheter is provided that has a notch portion that circulates in the circumferential direction and communicates the space on the distal end side with respect to the hub attachment portion and the communication portion. Assembly. The catheter assembly according to any one of claims 1 to 5,
The catheter assembly according to claim 1, wherein the support member includes a valve body displacement restricting unit that restricts a displacement of the valve body in an axial direction with respect to the first holding portion. The catheter assembly according to any one of claims 1 to 6,
The catheter assembly according to claim 1, wherein the support member includes a seal member displacement regulating unit that regulates an axial displacement of the seal member with respect to the second holding portion. The catheter assembly according to any one of claims 1 to 7,
The second holding part is formed thinner than the first holding part. A catheter assembly according to the present invention. The catheter assembly according to any one of claims 1 to 8,
The catheter assembly according to claim 1, wherein an axial length of the second holding portion is longer than an axial length of the seal member. The catheter assembly according to any one of claims 1 to 9,
The catheter assembly, wherein the seal member is a sintered body.

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